The FDA Inspection is one of the most stressful events in life of regulatory professional and a drug/device manufacturing establishment as a whole. Although you need to ensure your quality system is effective and always ready to pass the scrutiny, but many a times companies make basic mistakes during and after inspection which leads to 483s, warning letters and sometimes seizures.
Key questions to understand , Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? What documents I need to show? Are they ever going to leave? What do I do after it is over ?
This easy to use FDA Inspection readiness training guide will showcase how you can be ready anytime to face an FDA inspection and pass it with flying colors. It will showcase how you prepare yourself and team before inspection, what roles required and their skills, the FDA inspection process, checklist of items you need to have handy to use anytime and what are the do’s and don’t before, during and after inspection.
Approximate Duration 60 minutes.
The Training Package enables you to deliver your own training with ready-to-use, customizable slides, trainer notes . Why pay annually for online training that can’t be tailored to your needs?
Package contains :
- Course Presentation Slides PPT
- An instructor PDF containing slides and class room Instructions to talk ( Transcription of Audio )
- Student PDF document with notes to write during the class
Learning Objectives :
- What are common errors that fails a FDA Inspection
- FDA Inspection approach
- Types of Inspections
- Preparation before and during the inspection
- Inspection preparedness strategy and planning
- Key roles during an inspection & skills
- SME (Subject Matter Expert) training
- Facility resources to support the inspection
- The step by step Inspection process
- How to manage an inspection
- Behavior during inspection: What to say and do, and what NOT to say and do
- Checklists to refer in order to be successful (Management, CAPA, Complaint handling/MDR, Manufacturing, Calibration, Sterilization, Design Control, Data Integrity )
- How and when to craft a written response
- Common mistakes to avoid
Price : 
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